Imaging of High Grade Prostate Cancer

Prostatic Carcinoma Clinical Trial

Official title:

Detection of Malignant Calcifications in High Grade Prostate Cancer With Comedo-type Necrosis Using Thin Section Computed Tomography and Susceptibility Weighted Magnetic Resonance Imaging

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02177526
• Other study ID #: Malignant Prostate 100
• Status: Terminated
• Phase: N/A
• First received: June 18, 2014
• Last updated: November 17, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Management of prostatic carcinoma varies according to stage of disease. Trans-rectal ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling and random non-targeted technique. Methods to improve pre-operative tumor localization and grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area of research but requires further validation.

High grade tumors can undergo comedo-type necrosis with malignant calcifications which only occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI.

Detection of malignant calcification within tumor foci will improve the accuracy of localization and grading in prostatic carcinoma.

Description:

High grade (Gleason pattern 5) tumors can undergo comedo-type necrosis producing malignant calcifications which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI. Detection of malignant calcifications in areas of Gleason pattern 5 tumor will improve the accuracy of pre-operative localization and grading in prostatic carcinoma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies

• Patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification

Exclusion Criteria:

• Patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostatic Carcinoma
• Prostatic Neoplasms

Intervention

Device:
• Imaging
15 patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies will be enrolled after obtaining informed consent. 15 patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification will serve as a comparison group after providing informed consent for a total of 30 patients.

Locations

Country	Name	City	State
Canada	Ottawa Hospital (Civic Campus)	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of prostate patients with comedo-type necrosis.	Two radiologists will review the MRI and CT examinations separated by a 4 week interval to decrease recall bias. Further, readers will review the 3 additional gradient echo pulse sequences independently at 3 different MRI reading sessions, also separated by 4 weeks, in order to compare the accuracy from each pulse sequence and to reduce recall bias.	up to 4 weeks	No
Secondary	The number of other features measured on MRI.	Two radiologists will review the MRI and CT examinations separated by a 4 week interval to compare other MRI features and clinical factors between Gleason pattern 5 tumors with and without malignant calcification.	up to 4 weeks	No